Operation Manual Woodpecker - Woodpecker Operation Manual

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Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Operation Manual

  Woodpecker™

                    IMT Integral Medizintechnik AG

                    Haldenstrasse 5

                    6006 Luzern

                    Switzerland

                    Tel: +41 41 210 54 34
                    Fax: +41 41 210 54 38
                    info@imt-medical.com
                    www.imt-medical.com
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Table of Contents
 Introduction                                                                                                  1
   Proprietary Notice ..................................................................................... 1
   Limited Warranty....................................................................................... 1
   Service Support ........................................................................................ 1

 Indications for Use                                                                                           2

 Warnings, Cautions and Notes                                                                                  3

 Theory of Operation                                                                                           5
   Theory....................................................................................................... 5
   Advantages of using the Woodpecker ...................................................... 5

 Instructions for use                                                                                          6
 Cleaning and Sterilization                                                                                  17

 Maintenance                                                                                                 18

 Troubleshooting                                                                                             19

 Specifications                                                                                              20
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Introduction
Proprietary Notice
 Information contained in this document is copyrighted by IMT Integral
 Medizintechnik AG and may not be duplicated in full or part by any person
 without prior written approval of IMT Integral Medizintechnik AG. Its purpose is
 to provide the user with adequately detailed documentation to efficiently install,
 operate, maintain for the device supplied. Every effort has been made to keep
 the information contained in this document current and accurate as of the date
 of publication or revision. However, no guarantee is given or implied that the
 document is error free or that it is accurate with regard to any specification.

Limited Warranty
 IMT Integral Medizintechnik AG warrants each new Woodpecker and
 accessories to be free from defects in workmanship and materials under normal
 use and service for a period of one (1) year from the date of shipment. IMT
 Integral Medizintechnik AG sole obligation under this warranty will be to repair
 or replace, at its option, products that prove to be defective during the warranty
 period. The foregoing shall be the sole warranty remedy. Except as set forth
 herein, seller makes no other warranties, either expressed or implied, including
 the implied warranties of merchantability and fitness for a particular purpose. No
 warranty is provided if the products are modified without the express written
 consent of IMT Integral Medizintechnik AG and seller shall not be liable in any
 event for incidental or consequential damage. This warranty is not assignable.

Service Support
 If the device needs repair, contact an authorized IMT service center. When
 calling, have the Woodpecker(s) serial number(s) ready. If you need to ship the
 device, pack the device in its original packing materials, if possible, to prevent
 shipping damage. You are responsible for all shipping and insurance costs to
 and from IMT unless otherwise specified.

 IMT Integral Medizintechnik AG              IMT Innovative Medizin-Technik
 Head Office                                 Siegfried Schmal
 Haldenstrasse 5                             Westend 34
 CH-6006 Luzern                              DE-82377 Penzberg
 Switzerland                                 Germany
 Tel: +41 41 210 54 34                       Tel: +49 8856 9395 53
 Fax: +41 41 210 54 38                       Fax: +49 8856 9395 54
 info@imt-medical.com                        s.schmal@imt-medical.com

                                                                                      1
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Indications for use

The Woodpecker is indicated for:

  •   Health Care professionals trained and licensed in Orthopaedic Surgery

  •   Patients undergoing Total Hip Anthroplasty (THA).

  •   Use in femoral broaching

  •   This device is intended for multiple patient uses with approved cleaning and
      sterilization prior to reuse.

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Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Warnings, Cautions and Notes

 A warning indicates something that could hurt the patient/operator.

 A caution indicates something that could damage the device.

 A note indicates other important information.

 WARNING: Always start with the smallest broach.

 WARNING: Rotation during insertion of the broach is not recommended. If
 done, this could cause axial or rotational pressure and fracture of the femur.

 WARNING: Do not attempt to completely broach the intramedullary canal in one
 pass. Forward pressure must be exerted for cutting; pull back while running to
 clear bone debris.

 WARNING: Forceful insertion of the final broach using a mallet or other
 instrument is not recommended. If done, this could cause axial pressure and
 fracture.

 WARNING: Operating at pressures higher than 120 PSI (8 bar) may result in
 personal injury or damage to the Woodpecker.

                                                                                  3
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Warnings, Cautions and Notes

 WARNING: There are no user serviceable components on the Woodpecker.
 Any attempt at making repairs by a non-authorized service center may result in
 personal injury or damage to the Woodpecker.

 CAUTION: Use nitrogen or clean, filtered compressed air to power this
 instrument.

 CAUTION: Immersion or power washing is considered abuse; any resulting
 damage is NOT covered under the manufacturer’s warranty and will be repaired
 at the owner’s expense.

 NOTE: Using less than 100 PSI (7 bar) of air pressure may cause unsatisfactory
 broaching results

 NOTE: Remove all watches and jewelry when operating the Woodpecker. 70 Hz
 frequency may cause damage to watches or jewelry.

                                                                                  4
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Theory of Operation
Theory
•   The Woodpecker is a pneumatically powered device. The linear motion of the
    Woodpecker has a total travel of 10 mm (.3937 inches) and operates at 70 Hz
    (70 times per second). This linear back and forth motion of the Woodpecker
    creates an efficient cutting movement on the forward stroke and clearing of
    bone chips on the backward stroke, preventing the broach from
    wedging/jamming in the cortical bone. The Woodpecker exerts no more than
    1.0 newton of axial force on the femoral bone.

What’s great about pneumatic broaching with the
Woodpecker
•   Accurate shaping of the femoral canal provides improved fit. Gaps between
    the bone and the prosthesis are avoided. Non-physiological dilation of the
    femur, damage to the cortical bone and fissures are minimized substantially.

•   The high-frequency axial impulses of the Woodpecker reduce operation time.

•   Like thousands of other Surgeons have already discovered, you too will agree
    that the Woodpecker gives you precise control, yielding consistent results;
    every time.

•   The extremely low-level impulses of the Woodpecker
    - Minimizes Hoop stresses and decreases the bone marrow emboli risk.
    - Lower the risk of femoral fractures caused by excessive radial forces

•   Broaches or Adapters can be orientated in 90° increments to accommodate
    Surgeon preference or approach

                                                                                   5
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Instructions for use
                         The Woodpecker

 1. Upgrade Nosepiece

 2. Lock/Release Push Button

 3. Trigger Button

 4. Force Control Knob

 5. Trigger Bar

 6. Quick Connect for Hose Assembly

 7. Housing

                                                       6
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Power

 The Wodpecker is a pneumatically powered device and must be operated at a
 pressure of 100-120 PSI (7-8 bar). Use nitrogen or clean, filtered compressed
 air to power this device.

 •   Air Hose

 The Woodpecker is operated with a twin-hose (inner-hose Æ 18m and air outlet
 hose).

 Bent or kinked hoses may prevent the unit from operating satisfactorily.

                1. Quick disconnect fitting (on the left) to the Woodpecker
                   (female)

                2. Connection (on the right) to air supply (male)

                                                                                 7
Operation Manual Woodpecker - Woodpecker Operation Manual
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Pull hose quick-disconnect outer-shell back and attach the hose to the
     Woodpecker

 •   Slide quick-disconnect outer-shell in direction shown to secure hose to the
     Woodpecker.

                                                                                   8
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Wall manifold connection

                                                       9
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Filter connection

                                                       10
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Extension connection

                                                      11
Woodpecker Operation Manual

Instructions for use (cont.)
 •   IMT AG recommends starting at 100 PSI (7 bar). Effective pressure range is
     100 to 120 PSI (7-8 bar).

 WARNING: Operating at pressures higher than 120 PSI (8 bar) may result in
 personal injury or damage to the Woodpecker.

 •   Set force control knob to the minus setting.

 IMT AG recommends beginning the procedure at the minus (-) position. This
 allows the Orthopaedic Surgeon to work efficiently in Type C cortical bone.
 Moving the dial toward the plus (+) position increases the force required to
 broach Type A cortical bone.

                                                                                  12
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Press trigger bar to test

 •   Select broach adapter compatible with the femoral hip system to be
     implanted. This may very depending on the hip system being used.

                                                                          13
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Press down and hold button on upgrade nose piece. Insert adapter to
     preferred orientation.

 •   Press lock/release push button to lock adapter into place.

 •   To remove or change orientation of adapter, press and hold lock/release
     push button and remove or readjust adapter.

                                                                               14
Woodpecker Operation Manual

Instructions for use (cont.)

•   Insert broach into broach adapter. Lock into place.

     NOTE: Broach and adapter shown are for illustration purposes only. Broach and
adapter types, shapes, mounting and clamping methods may vary from manufacturer
to manufacturer.

                                                                                     15
Woodpecker Operation Manual

Instructions for use (cont.)

 •   Always begin with the force control set to the minus (-) setting.

 •   Always start with the smallest broach.

 •   Do not attempt to broach the intermedullary canal in one pass.

 •   The linear back and forth motion of the Woodpecker creates an efficient
     cutting movement on the forward stroke and clearing of bone chips on the
     backward stroke, preventing the broach from wedging/jamming in the cortical
     bone.

 •   When using the Woodpecker run the unit continuously while broaching. Do
     not start and stop the unit while broaching.

 •   The Woodpecker is a pneumatically powered device and must be operated at
     a pressure of 100-120 PSI (7-8 bar).

 •   To obtain a precise, prosthesis seating over a large surface, it is sufficient to
     continue broaching until the instrument can not insert the broach any further
     due to resistance from the cortical bone.

 •   Forceful insertion of the final broach using a mallet or other instrument is not
     recommended. If done, this could cause axial pressure and fracture.

                                                                                         16
Woodpecker Operation Manual

Instructions for cleaning

 The Woodpecker and accessories are supplied non-sterile.

 ° Washing

 This is done in the usual fashion by autoclaving

 All implants and instruments, which are supplied non-sterile, are packaged
 individually in shipping/storage boxes or plastic bags.

 To clean them prior to their first use or after surgery, we recommend a neutral
 PH (or slightly alkaline detergent according to the recommendations of the
 detergent manufacturer. Put the stericup on for washing.

 All instruments should then be thoroughly rinsed and dried prior to steam
 sterilization.

 ° Sterilization

 The stericup must be removed before sterilization.

 We recommend autoclaving according to standard hospital sterilization
 procedures and within the guidelines of the autoclave manufacturer, to assume
 a Sterility Assurance Level (SAL)
Woodpecker Operation Manual

Maintenance and Service
 •   It is recommended that the Woodpecker be serviced regularly at an
     authorized IMT service center. The Woodpecker will be completely
     disassembled, inspected, thoroughly cleaned, relubricated, reassembled
     and tested.

      CAUTION: There are no user serviceable components. Any attempt at making
      repairs by a non-authorized service center may result in personal injury or
      damage to the Woodpecker and will void the manufacturer’s warranty

                                                                                    18
Woodpecker Operation Manual

Troubleshooting
 If you observe any of the following, contact IMT AG for service.

             Problem                      Possible Cause

             Broach adapter sticks in     Nosepiece is damaged
             upgrade nosepiece            or dirty

             Trigger button sticking      Damaged O-rings

             Air leaking from             Damaged O-rings
             Woodpecker

             Unit is pressurized but      Piston may be stuck
             the Woodpecker doesn’t
             start

             Air leaking from hose,       Hose damaged
             hose fittings or exhaust
             jacket

                                                                    19
Woodpecker Operation Manual

  Specifications

     •   Woodpecker

         Effective operating pressure: 100 PSI to 120 PSI (7 to 8 bar)

         Total Stroke: 10 mm (0,3937 Zoll/Inches)

         Oscillation frequency: 70 Hz (70 times per second)

         Air consumption:        275 to 300 liters per minute

         Size:      Length: 25 cm (9,8 Zoll/Inches)
                    Height: 19,6 cm (7,7 Zoll/Inches)
                    Width: 5,9 cm (2,3 Zoll/Inches)

         Weight: 2,3 kilograms (5 pounds)

         Air Consumption: 250 – 300 liters per minute

     •   Air hose

         Twin-hose (inner-hose Æ 18 mm and air outlet hose).

The information above is subject to change. Please contact IMT AG for details or visit
us at www.imt-medical.com for the latest in Woodpecker supplies and accessories.

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Woodpecker Operation Manual

Notes
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